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Securities and Exchange Commission (SEC) Biosimilars

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Merck Announces Filing of Form 10 Registration for Spinoff Organon & Co.

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On March 17, 2021, Merck announced that it had filed a Form 10 registration statement with the U.S. Securities and Exchange Commission in order to spinoff its women’s health, biosimilars and established brands businesses into...more

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Coherus Implements Restructuring Plan Following Complete Response Letter For Its Pegfilgrastim Biosimilar

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As we reported here on June 12, 2017, Coherus BioSciences received a complete response letter (“CRL”) from the FDA for its biologics license application for its pegfiltrastim (Neulasta®) biosimilar. On June 21, 2017, in a...more

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